Commercial agreement for entry of Cxbladder to DHBs

The Health Innovation Hub (HIH)
has signed a commercial agreement to engage District Health
Boards in the adoption of Pacific Edge’s non-invasive
bladder cancer detection system Cxbladder, making it
accessable for nearly one out of every two New
Zealanders.

As a result of the agreement Cxbladder will be
considered for use to evaluate patients presenting with
haematuria, a symptom of possible bladder cancer, in clinics
operated by the four largest District Health Boards (DHBs),
Auckland, Waitemata, Counties Manukau and Canterbury.

The
HIH is a recently formed government enterprise with a
mandate to enable technology commercialisation into and out
of the country’s four largest DHBs.

“Cxbladder has been clinically
tested in some of these DHBs, in conjunction with their
respective urologists who work in both the public arena and
private practice. The decision of HIH to now assist the
adoption of Cxbladder is a strong endorsement of its ability
to deliver sound clinical outcomes for patients and
significant savings in time and expense for
DHBs.”

Cxbladder has recently also completed a blinded
User Program in both Waitemata and Canterbury DHBs with
outstanding results validating Cxbladder in these clinical
settings.

“It was particularly pleasing to see such
great results from these blinded studies, confirming the
outcome of the large clinical study published in the Journal
of Urology in the United States in September 2012,” says
David Darling.

"Pacific Edge is an
innovative New Zealand company with demonstrated export
potential. The Health Innovation Hub is passionate that New
Zealanders should benefit from access to the same innovative
health products that international markets do. Cxbladder is
an exciting innovation with the potential to bring benefits
to millions of people who show the symptoms of or need
monitoring for bladder cancer.”

The agreement with HIH
builds on a momentous 12 months for Pacific Edge. During
2013 the Dunedin-based cancer diagnostic company attained
regulatory approval from CLIA, for both the Dunedin
commercial laboratory and its purpose built Cxbladder
testing laboratory in Hershey, Pennsylvania. In the United
States, the world’s largest healthcare market, Cxbladder
has been commercially launched, achieved sales and signed
agreements with several large national provider networks to
give more than 50 million Americans access to the bladder
cancer diagnostic system. Other milestones included an
agreement with Mid Central DHB based in Palmerston North to
use Cxbladder to evaluate patients presenting with
haematuria.

Cxbladder detects nearly 100 per
cent of urothelial carcinomas, in preference to cytology for
the detection and monitoring of patients who may have
bladder cancer.

Pacific Edge Chief Executive Officer David
Darling says the Government must be congratulated for
creating the Health Innovation Hub in 2011 as a catalyst for
the commercialisation of new innovative medical technologies
coming from, and entering the health technology sector.
There are a number of significant changes taking place in
the procurement and adoption of step-change technology in
the healthcare system New Zealand and part of those changes
is a more expedient process for adoption of technology that
will lower cost and or improve patient outcomes.

“New
Zealanders will be the real winners of this initiative. Half
the population are now able to more expediently access
Cxbladder technology providing a highly accurate and
efficient alternative to the other diagnostic techniques now
commonly used. The option of patients being able to give a
urine sample at home and for clinicians to receive the
results a few days later has the potential to offer DHBs
significant cost benefits by reducing the number of patients
requiring a full clinical work-up.”

In addition to
Pacific Edge's own subsidiaries offering Cxbladder in the
United States and NZ, Cxbladder is being marketed in
Australia by Healthscope, a leading healthcare provider, and
is due to be launched in Spain, which has one of the highest
incidences of bladder cancer, this year.

ABOUT PACIFIC
EDGEPacific Edge Limited (NZX: PEB) is a New
Zealand based cancer diagnostic company specialising in the
discovery and commercialisation of diagnostic and prognostic
technology for the early detection and monitoring of cancer.
Products in development and in clinical trials are accurate
and simple to use genomic and proteomic tools for the
earlier detection, improved characterisation and better
management of gastric, bladder, colorectal cancers and
melanoma. The company has completed and released its first
product for the detection of bladder cancer, Cxbladder, and
is actively marketing the product to physicians and
clinicians in New Zealand, Australia and the USA and soon in
Spain.www.pacificedge.co.nzABOUT PACIFIC
EDGE DIAGNOSTICSPacific Edge takes its exciting
cancer detection tests to market through its wholly owned
subsidiaries, Pacific Edge Diagnostics NZ Ltd and Pacific
Edge Diagnostics USA Ltd, and selected commercial partners
in Australia and Spain, Healthscope and Oryzon
respectively.www.pacificedgedx.com

ABOUT
CxbladderCxbladder is a proprietary, accurate
molecular diagnostic test that enables the non-invasive
detection of bladder and other urinary tract cancers from a
small volume of urine. Cxbladder is commercialised in the
USA as a Laboratory Developed Test (LDT). It provides
physicians and clinicians with a quick, cost effective and
accurate measure of the presence of the cancer, and provides
urologists with the opportunity to reduce their reliance on
the need for invasive tests such as cystoscopy. The
Cxbladder cancer detection test has been validated by a
multicentre, international clinical study. Results
published in the Journal of Urology (Sept 2012) show that
Cxbladder out-performed all of the benchmark
technologies in the clinical trial and detected nearly all
of the tumours of concern to a urologist; At a performance
of 82% sensitivity and 85% specificity the test sees 100% of
T1, 100% of T2, 100% of T3, 100% of Tis and 100% of upper
urinary tract cancers as well as greater than 95% of high
grade tumours.www.cxbladder.comABOUT BLADDER
CANCERGlobally, bladder cancer has the 9th
highest incidence and the 4th highest incidence for men. One
of the early symptoms of bladder cancer is the presence of
blood in the urine, haematuria. People with haematuria often
present to their general practitioner before being referred
on to a urologist.

There are a number of ‘at risk’
occupations that have shown a much higher incidence of
bladder cancer. Fire fighters and fire control officers have
shown in a US study to have a twice the incidence of bladder
cancer over non fire fighters. Smoking is a significant
contributing factor (over 50% in males and 33% in females,
and approximately one of every two new incidences of bladder
cancer is linked to smoking). Exposure to certain industrial
chemicals or carcinogens increases risks for some
occupations e.g. hairdressers, painters, printers, fire
fighters and metal workers and chemical engineers. Incidence
increases with age so the older you are, the greater the
potential for bladder cancer.

Bladder cancer has a very
high recurrence rate of approximately 50%-70% with up to 30%
of these recurring as later stage tumours. This is a higher
recurrence than for skin cancer! However, bladder cancers
are highly treatable, especially if detected in the early
stages. If diagnosed early there is a much higher
probability of survival for early stage tumours relative to
later stage tumours. This makes timely and regular
surveillance and monitoring of this cancer a key element of
the clinical process and of the individual’s annual
healthcare plan.

ABOUT New Zealand Health
Innovation HubThe New Zealand Health Innovation
Hub’s purpose is to build a healthier world through smart
innovation by becoming a world leader in accelerating
health-related innovations from ideas to market through the
establishment and on-going development of strategic
partnerships, accelerateing product and service realisation,
and leveraging the capilities and resoureces within the
public healthcare sector and particpating DHB’s to
optimise healthcare
benefits.innovation.health.nz

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